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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03497000
Other study ID # Peking UPH
Secondary ID
Status Completed
Phase N/A
First received March 28, 2018
Last updated April 14, 2018
Start date September 1, 2017
Est. completion date March 27, 2018

Study information

Verified date April 2018
Source Peking University People's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

OCTA-guided PDT is as safe and effective as ICGA-guided PDT in the treatment of acute central serous chorioretinopathy. Or OCTA-guided PDT is more effective than ICGA-guided PDT in the treatment of acute central serous chorioretinopathy, safe as well.


Recruitment information / eligibility

Status Completed
Enrollment 23
Est. completion date March 27, 2018
Est. primary completion date December 1, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Idiopathic detachment of the neurosensory retina with a focal leak at the level of the RPE with FA

- Presence of SRF and/or serous pigment epithelial detachment on OCT

- Presence of abnormal dilated choroidal vasculature in ICGA

Exclusion Criteria:

- Patients with other ocular conditions commonly associated with SRF, such as choroidal neovascularization, polypoidal choroidal vasculopathy (PCV), diabetic retinopathy, retinal vascular occlusion, Coat's disease

- Any disease that may affect the quality of imaging (quality of OCTA images < 6), such as cataract, high myopia or nystagmus

- History of ocular surgeries including retinal laser

- Pregnancy

- Any uncontrolled systemic disease

- Any condition rendering patients intolerable to image acquisition

Study Design


Intervention

Procedure:
OCTA-guided Photodynamic therapy
Half-dose photodynamic therapy using verteporfin under the guidance of OCTA
ICGA-guided Photodynamic therapy
Half-dose photodynamic therapy using verteporfin under the guidance of ICGA

Locations

Country Name City State
China People's Hospital of Peking University Beijing Beijing

Sponsors (2)

Lead Sponsor Collaborator
Peking University People's Hospital National Natural Science Foundation of China

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of patients with subretinal fluid resolution on OCT after PDT of two groups 3 months
Secondary Number of patients with leakage point resolution on FFA after PDT of two groups 3 months
Secondary Number of recurrent CSC after PDT of two groups 3 months
Secondary BCVA (best corrected visual acuity) at every follow-up of two groups 1 month, 3 months
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